Faecal Microbiota Transplantation as Means of Preventing Recurrent Urinary Tract Infections (FMT-UTI)

This study investigates Faecal microbiota transplantation (FMT) in prevention of recurrent urinary tract infections (UTIs) caused either by sensitive E. coli or ESBL-E. coli.

Study Overview

• Status: Recruiting
• Conditions: Recurrent Urinary Tract Infection
• Intervention / Treatment: Biological: Feacal microbial transplantation (FMT); Other: Placebo transplantation (PT)

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Sari Pakkanen, PhD; Phone Number: +358 +358 50 4482769; Email: vti-tutkimus@hus.fi

Study Locations

• Finland
  • Helsinki, Finland, 00290
    • Recruiting
    • Meilahti Vaccine Research Center, Helsinki University Central Hospital
    • Contact: Sari Pakkanen, PhD; Email: sari.pakkanen@hus.fi
    • Contact: Meilahti Vaccine Research Center; Email: vaccine@hus.fi
    • Sub-Investigator: Hanni Häkkinen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

• Female subjects aged ≥18
• History of recurrent UTI: at least two episodes of UTI over the past 6 months or at least three episodes over the past year, most recent episode within the past three months
• Written informed consent

Exclusion criteria:

• Suspected non-compliance
• Diagnosis of a gastrointestinal disease
• Pregnancy
• Immunosuppression
• Any kind of permanent urinary catheter or intermittent urinary catheterization
• Any other criteria which, in the investigator's opinion, would compromise the ability of the subject to participate in the study, the subject's well-being, or the outcome of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Feacal microbial transplantation (FMT)	Biological: Feacal microbial transplantation (FMT); Feacal microbial transplantation (FMT)
Placebo Comparator: Placebo transplantation (PT), transplantation with coloured 0,9% NaCl-solution	Other: Placebo transplantation (PT); Transplantation with coloured 0,9% NaCl-solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
mean number of UTI episodes after FMT among patients with recurrent UTI	12 months
proportion of participants with UTI after FMT among patients with recurrent UTI	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean number of UTI episodes caused by sensitive E. colis after FMT among patients with recent non-ESBL/MDR UTIs		12 months
proportion of participants with UTIs caused by sensitive E. colis after FMT among patients with recent non-ESBL/MDR UTIs		12 months
mean number of UTI episodes caused by ESBL/MDR E. colis after FMT among patients with recent ESBL/MDR UTIs		12 months
proportion of participants with UTIs caused by ESBL/MDR E. colis after FMT among patients with recent ESBL/MDR UTIs		12 months
identifying groups of bacteria associated with smaller number of UTI episodes after FMT		12 months
the duration of successful prevention by FMT		1-5 years
proportion of participants with recurrent UTI and concurrent intestinal MDR colonisation with the same strain		12 months
proportion of participants with intestinal ESBL/MDR eradicated after FMT		1-12 months
confirm whether the uropathogen are identical before and after FMT	evaluated by antimicrobial sensitivity profile and whole-genome sequencing	12 months
number of antibiotic courses received by FMT versus placebo recipients		12 months
proportion of participants with gastrointestinal symptoms assessed by GSRS scores before and after FMT	Gastrointestinal symptom rating scale -questionnaire with 15 items on a 7-level Likert scale (1-7), higher scores for more intense symptoms during the past week	1-12 months
proportion of participants with mild to severe depression assessed by BDI scores before and after FMT	Beck's Depression Inventory: 21-question multiple-choice self-report inventory, higher scores for more severe depression	1-12 months
mean number of health-related quality of life (HRQoL) scores assessed by 15D before and after FMT	Quality of life -questionnaire (15D): a generic, comprehensive (15-dimensional), self-administered questionnaire, lower scores for better HRQoL	1-12 months
description of groups of bacteria in faecal and urine microbiome before and after FMT		12 months
human urine and serum metabolic profiles before and after FMT	assessed by a 1H-Nuclear Magnetic Resonance-based metabolomic approach	12 months

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Collaborators: University of Helsinki

Publications and helpful links

Helpful Links

• HUS informational website for recruitment

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: August 29, 2023
• First Submitted That Met QC Criteria: September 15, 2023
• First Posted (Actual): September 22, 2023

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: UTI; Recurrent urinary tract infection; Urinary tract infection, Faecal microbiota transplantation, ESBL, Antimicrobial resistance
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections; Communicable Diseases; Recurrence; Urinary Tract Infections
• Other Study ID Numbers: FMT-UTI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No